Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000383662
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
13/09/2005
Date last updated
13/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of ethanol to prevent infection in tunnelled intravenous catheters in haematology patients treated with chemotherapy.
Scientific title
A Prospective double-blind randomised clinical trial of 70% ethanol to prevent luminal microbial colonisation of tunneled catheters and associated catheter related sepsis, in haematology patients treated with chemotherapy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intravascular tunneled central line catheter related sepsis. 487 0
Condition category
Condition code
Blood 566 566 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To assess the efficacy ans safety of 70% ethanol in preventing luminal colonisation of central venous tunnelled catheters. 70% Ethanol or Heparin/saline will be installed into the lumen of the catheter daily for a duration of 2 hours before being removed. This intervention will continue for the length of the hospital admission for the patient or to a limit of 30 days.
Intervention code [1] 422 0
Prevention
Comparator / control treatment
Control (heparin/saline)
Control group
Placebo

Outcomes
Primary outcome [1] 649 0
Will the introduction of 70% Alcohol down the lumen of a central line catheter reduce the incidence of bacterial colonisation of the lumen in haematology in-patients receiving chemotherapy.
Timepoint [1] 649 0
Secondary outcome [1] 1344 0
To assess the usefulness of the FAS brush in diagnosis of Catheter related sepsis.
Timepoint [1] 1344 0
Fas brushing will occur at the following time points in the trial.
1. First febrile episode
2. Second febrile episode or if temperature continues for 7 days
3. Discharge from Hospital.

Eligibility
Key inclusion criteria
Consent. Central venous catheter in-situ For chemotherapy requiring an in-patient stay for >5 days. Haematological malignancy / Bone marrow transplant.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known allergy to ethanol. Out-patient chemotherapy. Positive central line cultures within 7 days of entry into study. Elevated LFTs (>2.5 times above ULN). Known history of alcoholism. Pregnancy/lactating women Febrile above 38.0deg at entry.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There was one unblinded pharmacist who kept the randomisations in a different department to where the study was being conducted. Randomisation occurred by fax.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation was performed using Microsoft Excel 97.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 189 0
New Zealand
State/province [1] 189 0

Funding & Sponsors
Funding source category [1] 617 0
Charities/Societies/Foundations
Name [1] 617 0
Canterbury District Health Board Research Fund
Country [1] 617 0
New Zealand
Primary sponsor type
Government body
Name
Canterbury District Health Board
Address
Country
New Zealand
Secondary sponsor category [1] 502 0
None
Name [1] 502 0
None
Address [1] 502 0
Country [1] 502 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1733 0
Upper South regional Ethics committee
Ethics committee address [1] 1733 0
Ethics committee country [1] 1733 0
New Zealand
Date submitted for ethics approval [1] 1733 0
Approval date [1] 1733 0
Ethics approval number [1] 1733 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35395 0
Address 35395 0
Country 35395 0
Phone 35395 0
Fax 35395 0
Email 35395 0
Contact person for public queries
Name 9611 0
Alan Pithie
Address 9611 0
Christchurch Hospital
PO Box 4710
Christchurch
Country 9611 0
New Zealand
Phone 9611 0
+64 3 3640640
Fax 9611 0
Email 9611 0
[email protected]
Contact person for scientific queries
Name 539 0
Joanne Sanders
Address 539 0
Canterbury Health Laboratories
PO Box 151
Christchurch
Country 539 0
New Zealand
Phone 539 0
+64 3 3640377
Fax 539 0
+64 3 3640750
Email 539 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.